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Prospective imaging trial (n=50)PubMedEuropean Urology

Prospective Comparison of ⁶⁴Cu-SAR-bisPSMA vs ⁶⁸Ga-PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer (Co-PSMA Trial)

Khan S, Papa N, Kneebone A, Eade T, Ayati N, et al.

Summary

In 50 men with biochemical recurrence of prostate cancer (PSA 0.2-0.75 ng/ml), ⁶⁴Cu-bisPSMA PET/CT detected 2.63x more lesions than ⁶⁸Ga-PSMA-11 (mean 1.26 vs 0.48 per patient, p<0.0001). 78% were positive on ⁶⁴Cu-bisPSMA versus 36% on ⁶⁸Ga-PSMA, with management changed in 44% of patients between scans.

Clinical Significance

This bivalent PSMA peptide imaging agent with its 12.7-hour half-life dramatically outperforms the current standard of care for detecting prostate cancer recurrence. The 44% management change rate demonstrates substantial clinical impact for guiding treatment decisions in recurrent prostate cancer.

Key Findings

  • Detection rate: 2.63x more lesions with ⁶⁴Cu-bisPSMA vs ⁶⁸Ga-PSMA-11
  • Sensitivity: 78% vs 36% positivity rate
  • True positive rate: 71% vs 29% against reference standard
  • False negative rate: 21% vs 65% (⁶⁴Cu-bisPSMA superior)
  • Management impact: 44% of patients had treatment plan changes
  • Concordance: Triple-reader concordance 84% for ⁶⁴Cu-bisPSMA

Clinical Implications

The bivalent PSMA peptide design and longer half-life of ⁶⁴Cu allow delayed imaging at 24 hours, dramatically improving detection of recurrent disease at low PSA levels. This could become the new standard for PSMA-PET imaging in biochemical recurrence.

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